A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Part of paid clinical trials in Harrison, New York.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT03248310
- Status
- Recruiting
Conditions
- Lymphedema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Quality of Life Assessments — BEHAVIORALUpper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
Study Details
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
Key Dates
- Start date
- Aug 9, 2017
- Status verified
- Sep 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 600 participants (estimated)
Arms
- Arm: vascularized lymph node transfer (VLNT)This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
- Arm: non-surgical treatmentThis is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Primary Outcome Measure
Quality of Life [ Time Frame: up to 40 months ]
Central Contacts
- Babak Mahrara, MD646-608-8085
- Andrea Barrio, MD646-888-5118
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | Babak Mahrara, MD 646-608-8085 Andrea Barrio, MD 646-888-5118 |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Babak Mahrara, MD 646-608-8085 Andrea Barrio, MD 646-888-5118 |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Rockville Centre | New York | 11553 | Babak Mahrara, PhD 646-608-8085 |
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